Evaluation of Ultrasound Probe for Use in Bladder Radiotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University Hospital Birmingham NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr Anjali Zarkar, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01698359
First received: September 17, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

Muscle-invasive bladder cancer affects over 3,000 new patients in the UK each year and radiotherapy comprises a key part of the treatment pathway for many of them. Bladder radiotherapy in the UK involves delivery of radiation to the entire bladder volume and aims to deliver a high dose to the bladder while sparing nearby healthy organs (e.g. the bowel). Unfortunately, large variations in bladder shape and volume are observed throughout treatment that compromise the probability of a positive outcome for the patient, either by increasing the risk of side-effects or by reducing the likelihood of adequately treating the disease.

In recent years, the implementation of 'adaptive' bladder radiotherapy strategies has increased. These techniques allow modification of the treatment based on the observed variations in bladder shape and volume. However, these strategies often rely on daily X-ray imaging of the patient prior to treatment, which is time-consuming and associated with a small risk of inducing a cancer in the patient.

This study will evaluate the potential of a commercially available ultrasound probe for use as an alternative to X-ray scanning during treatment for these patients. The study will also aim to compare the likelihood of reducing side-effects and successfully treating the disease for the different adaptive strategies that are used around the world.


Condition
Bladder Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Ultrasound Probe for Use in Adaptive Bladder Radiotherapy

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • Accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement [ Time Frame: Three weeks ] [ Designated as safety issue: No ]
    The principal aim of this study is to quantify the accuracy of ultrasound measurement of bladder volume in comparision with gold standard MRI measurement. To do this, each of the five volunteers will have 5 repeat measurements of each imaging modality (ultrasound and MRI) within each 45 minute scan session as the bladder volume increases in response to the specified drinking protocol. Each volunteer will undergo three scan sessions over three weeks. Study participants will not receive follow-up. An accuracy of +/-10% would be considered sufficient to inform future studies.


Estimated Enrollment: 5
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers from within the staff of the Radiotherapy, Medical Physics and Oncology departments at the Queen Elizabeth Hospital

Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Pre-existing bladder conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698359

Contacts
Contact: Gareth Webster, PhD +44 (0) 121 37 1 5056 Gareth.Webster@uhb.nhs.uk
Contact: anjali Zarkar, FRCR 0121 371 3559 anjali.zarkar@uhb.nhs.uk

Locations
United Kingdom
University hospital Birmingham Not yet recruiting
Birmingham, west Midlands, United Kingdom, B15 2TH
Principal Investigator: Anjali Zarkar, FRCR MD MBBS         
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Investigators
Principal Investigator: Anjali Zarkar, FRCR UHB
  More Information

No publications provided

Responsible Party: Dr Anjali Zarkar, Consultant Clinical Oncologist, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01698359     History of Changes
Other Study ID Numbers: RRK4571
Study First Received: September 17, 2012
Last Updated: September 28, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014